Biological subject matter expertise from Scitech
The biotechnology industry continues to thrive and is widely considered to be a sector that will experience long-term growth as more innovative products and solutions are entering the market.
Within the UK, investment in the development of new medicines, bio-based chemicals, vaccines, and recent ground-breaking therapeutics such as cell and gene therapy products remain strong. Interest also continues to grow in innovative technologies impacting different sectors, by transforming the landscape for CO2-intensive industries, such as replacing additives derived from petroleum-based chemicals with biobased chemicals, biodegradable plastics, or alternative food and drinks from non-animal sources.
At Scitech, we are proud of our long history in supporting many biologics manufacturing organisations to either set-up, improve or scale up their laboratories, pilot plants, and GMP and non-GMP manufacturing facilities. We have in-house engineers with extensive experience such as expertise within biologics, some of which supported the development of the underlying biochemistry and bioprocessing principals in academia and industry and who have a successful track record of working in major biologics manufacturing and cGMP facilities in the UK.
Our in-house design and engineering team will work concurrently with client teams and can support projects at various stages of feasibility/concept study, scheme/basic design to detail design, construction, and commissioning/validation.
We hold significant experience and expertise within this sector and can support in the following areas:Read more
- Bioprocess design, process mapping, capacity analysis and debottlenecking of the existing manufacturing operation or production platforms.
- Upstream systems, including selection and specification of fermentation, cell culture systems and supporting systems.
- Downstream systems, including filtration, purification/chromatography and fill/finish systems.
- Hygienic design solutions suitable for aseptic/sterile processing in accordance with industry standards (ASME BPE) and guidelines (ISPE, PCI/S)
- Single use processing systems for bioreaction, separation, purification, buffer make-up and storage systems.
- Design of clean utility systems including process and mechanical design for purified water, Water for Injection (WFI), clean steam, clean process gases and CIP systems.
- Intensified bioprocessing systems such buffer In-Line Dilution (ILD) systems.
- Full validation lifecycle from URS development and GMP reviews through DQ/IQ/OQ and support during PQ.
- Full safety assessment and reviews (HAZID/HAZOP) and DSEAR/Hazardous Area Classifications (ATEX)